Systems and methods for delivery of therapeutic gas
Inventors
Acker, Jaron M. • Milsap, Jeff • Roehl, Robin • Schmidt, Jeffrey • Tolmie, Craig R.
Assignees
Mallinckrodt IP • Mallinckrodt Pharma IP Trading DAC • Mallinckrodt Pharmaceuticals Ireland Ltd • Therakos Inc • INO Therapeutics LLC • Mallinckrodt Critical Care Finance Inc
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Publication Number
US-11529479-B2
Publication Date
2022-12-20
Expiration Date
Abstract
Therapy gas delivery systems that provide run-time-to-empty information to a user of the system and methods for administering therapeutic gas to a patient. The therapeutic gas delivery system may include a gas pressure sensor attachable to a therapeutic gas source that communicates therapeutic gas pressure data to a therapeutic gas delivery system controller, a gas temperature sensor positioned to measure gas temperature in the therapeutic gas source that communicates therapeutic gas temperature data to the therapeutic gas delivery system controller, at least one flow controller that communicates therapeutic gas flow rate data to the therapeutic gas delivery system controller, at least one flow sensor that communicates flow rate data to the therapeutic gas delivery system controller, and at least one display that communicates run-time-to-empty to a user of the therapeutic gas delivery system. The therapeutic gas delivery system controller of the system includes a processor that executes an algorithm to calculate the run-time-to-empty from the data received from the gas pressure sensor, temperature sensor, flow controller and flow sensor, and directs the result to the display.
Core Innovation
The invention is an electronically controlled gas blending device for therapeutic gas delivery that includes a flow control channel receiving a therapeutic gas flow, a secondary shut off valve, a secondary flow control valve, a secondary delivery flow sensor, and a secondary confirmatory flow sensor. At a blending junction, a flow regulating valve is in fluid communication with the flow control channel and is operable to deliver the therapeutic gas to a primary outlet, a low pressure outlet, and an injector module.
The device further includes a low pressure confirmatory flow sensor in fluid communication with the primary outlet and a low pressure delivery flow sensor in fluid communication with the low pressure confirmatory flow sensor. A secondary delivery subsystem controller is electronically connected to the valves and sensors and receives a set dose of therapeutic gas and flow values from secondary sensors to calculate a therapeutic-gas flow rate and compare the delivered dose to the set dose.
The invention provides performance verification for electronically controlled therapeutic gas delivery, including pre-use and in-delivery confirmation of redundant delivery and confirmatory flow sensors via threshold-based agreement and mismatch. Flow control and valves are adjusted to create known flow changes and detect valve or sensor failures by comparing sensor-derived breathing-gas flow and therapeutic-gas blending ratio with gas analyzer subsystem measurements, including purge verification and failure processes and alarms/logging.
The device also documents failure detection and cross-checking using gas source identifier and gas pressure sensor inputs, including detection of incorrect or expired therapeutic gas sources and shut off valve actions. Verification further includes ratio-metric NO concentration calculation (YNOcalc) to cross-check gas concentration and flow measurements for failure triangulation and calibration or leak tests during purge and purge verification.
Claims Coverage
The claim coverage includes one independent electronically controlled gas blending device architecture with four core inventive features, supported by additional dependent refinements in the input text.
Secondary delivery flow sensing and shut off in a therapeutic flow control channel
A flow control channel operable to receive a therapeutic gas flow, the flow control channel in fluid communication with a secondary shut off valve, a secondary flow control valve, a secondary delivery flow sensor, and a secondary confirmatory flow sensor.
Flow regulating valve delivering to primary outlet, low pressure outlet, and injector module
A flow regulating valve at a blending junction, the flow regulating valve in fluid communication with the flow control channel and operable to deliver the therapeutic gas to a primary outlet, a low pressure outlet, and an injector module.
Low-pressure confirmatory and delivery flow sensing
A low pressure confirmatory flow sensor in fluid communication with the primary outlet; and a low pressure delivery flow sensor in fluid communication with the low pressure confirmatory flow sensor.
Secondary delivery subsystem controller electronically connected to valves and sensors
A secondary delivery subsystem controller in electronic communication with the secondary shut off valve, the secondary flow control valve, the secondary delivery flow sensor, the secondary confirmatory flow sensor, the flow regulating valve, the low pressure confirmatory flow sensor, and the low pressure delivery flow sensor.
Claim coverage centers on an electronically controlled gas blending device architecture combining secondary shut off and flow control with paired secondary delivery and confirmatory flow sensing, a flow regulating valve at a blending junction feeding a primary outlet, a low pressure outlet, and an injector module, and a secondary delivery subsystem controller electronically connected to the relevant valves and sensors.
Stated Advantages
Provides confirmatory sensing and redundant flow verification via secondary delivery and secondary confirmatory flow sensors and a low pressure confirmatory and delivery flow sensor arrangement.
Enables comparison of delivered dose to a set dose using low-pressure flow/confirmatory sensors.
Generates an alarm when low pressure confirmatory and low pressure delivery flow sensors report flow values that are not about the same.
Provides pressure monitoring via a pressure sensor connected to low-pressure flow sensors and/or the low-pressure outlet.
Provides overpressure protection by opening an overpressure valve at a predetermined pressure to prevent pressure surges.
Supports connection of a low pressure outlet to a manual ventilation device.
Documented Applications
Pre-use and in-delivery performance verification for an electronically controlled therapeutic gas delivery system, including purge and purge verification and failure processes and alarms/logging.
Detection of incorrect or expired therapeutic gas sources using gas source identifiers and gas pressure sensors, with shut off valve response.
Cross-checking during operation using ratio-metric NO concentration calculation (YNOcalc) and comparisons against a gas analyzer subsystem for failure triangulation and calibration or leak tests.
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